RETROVIR (ZIDOVUDINE) HAS BEEN ASSOCIATED WITH HEMATOLOGIC TOXICITY INCLUDING NEUTROPENIA AND SEVERE ANEMIA PARTICULARLY IN PATIENTS WITH ADVANCED HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE (SEE WARNINGS). PROLONGED USE OF RETROVIR HAS BEEN ASSOCIATED WITH SYMPTOMATIC MYOPATHY.
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING RETROVIR AND OTHER ANTIRETROVIRALS (SEE WARNINGS).
RETROVIR is the brand name for zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against human immunodeficiency virus (HIV).
RETROVIR in combination with other antiretroviral agents is indicated for the treatment of HIV infection.
Maternal-Fetal HIV Transmission: RETROVIR is also indicated for the prevention of maternal-fetal HIV transmission as part of a regimen that includes oral RETROVIR beginning between 14 and 34 weeks of gestation, intravenous RETROVIR during labor, and administration of RETROVIR Syrup to the neonate after birth. The efficacy of this regimen for preventing HIV transmission in women who have received RETROVIR for a prolonged period before pregnancy has not been evaluated. The safety of RETROVIR for the mother or fetus during the first trimester of pregnancy has not been assessed (see Description of Clinical Studies).
Media Articles Related to Retrovir (Zidovudine)
Added benefit not proven rilpivirine combination product in hiv-1 patients with previous antiretroviral treatment:
Source: HIV / AIDS News From Medical News Today [2014.04.09]
Only study cited in the dossier was too short / appropriate comparator therapy not implementedThe German Institute for Quality and Efficiency in Health Care (IQWiG) reassessed the antiviral...
Could transplant drugs replace antiretrovirals in HIV treatment?
Source: HIV / AIDS News From Medical News Today [2014.04.03]
A new study finds that drugs used to prevent transplanted organs from being rejected lower the count of HIV-infected blood cells in patients with HIV.
Despite antiretroviral therapy, hepatitis C remains major problem for HIV patients
Source: HIV / AIDS News From Medical News Today [2014.03.19]
A new study led by researchers at the Perelman School of Medicine at the University of Pennsylvania has found that the risk of hepatitis C-associated serious liver disease persists in HIV patients...
Tipping Point in the AIDS Epidemic
Source: Medscape Medical News Headlines [2014.04.11]
With the increasing use of antiretroviral therapy around the world, rates of HIV transmission are declining, life expectancy is increasing, and optimism about controlling HIV is growing.
Medscape Medical News
ART Use and Kidney Function: Clinical Practice Implications
Source: Medscape HIV/AIDS Headlines [2014.04.07]
What effect does antiretroviral therapy have on the kidney?
Published Studies Related to Retrovir (Zidovudine)
A randomized trial of punctuated antiretroviral therapy in Ugandan HIV-seropositive adults with pulmonary tuberculosis and CD4 T-cell counts of >/= 350 cells/muL. [2011.09.15]
BACKGROUND: Optimal treatment of human immunodeficiency virus (HIV)-associated tuberculosis in patients with high CD4 T-cell counts is unknown. Suppression of viral replication during therapy for tuberculosis may block effects of immune activation on T cells and slow HIV disease progression... CONCLUSIONS: Short-term antiretroviral therapy during tuberculosis treatment in patients with CD4T-cell counts of >350 cells/muL was safe and associated with clinical benefits.
Postexposure prophylaxis of breastfeeding HIV-exposed infants with antiretroviral drugs to age 14 weeks: updated efficacy results of the PEPI-Malawi trial. [2011.08.01]
BACKGROUND: This analysis updates and extends efficacy estimates of the PEPI-Malawi trial through age 24 months at study completion in September 2009... CONCLUSIONS: Daily infant antiretroviral prophylaxis reduces postnatal HIV infection by ~70% during the period of prophylaxis. But continued HIV transmission after prophylaxis stops suggests more prolonged infant prophylaxis is needed.
Timing of initiation of antiretroviral therapy in human immunodeficiency virus (HIV)--associated tuberculous meningitis. [2011.06]
BACKGROUND: The optimal time to initiate antiretroviral therapy (ART) in human immunodeficiency virus (HIV)-associated tuberculous meningitis is unknown... CONCLUSIONS: Immediate ART initiation does not improve outcome in patients presenting with HIV-associated tuberculous meningitis. There were significantly more grade 4 adverse events in the immediate ART arm, supporting delayed initiation of ART in HIV-associated tuberculous meningitis. Clinical Trials Registration. ISRCTN63659091.
Beliefs about antiretroviral therapy, treatment adherence and quality of life in a 48-week randomised study of continuation of zidovudine/lamivudine or switch to tenofovir DF/emtricitabine, each with efavirenz. [2011.06]
Adherence may be facilitated by reducing perceptual and practical barriers to antiretroviral therapy (ART). Practical barriers include the complexity of daily dosing, while perceptual barriers include perceptions of the need for treatment and concerns about adverse effects... Switching from CBV to TVD may improve patient reported outcomes including slightly better adherence, a greater reduction in concerns about adverse effects and less treatment intrusiveness.
Challenges in PMTCT antiretroviral adherence in northern KwaZulu-Natal, South Africa. [2011.06]
BACKGROUND: Women living with HIV in sub-Saharan Africa face significant challenges in accessing HIV care and adhering to antiretroviral therapy. Most reports have focused on issues relating to long-term adherence such as those surrounding stigma and disclosure, hunger, cultural factors, lack of accurate health information, lack of social support, medication side effects and overcrowded health systems. Information related to the challenges facing pregnant women when taking antiretrovirals for prophylactic purposes is limited. The "Kesho Bora Study" is a multicentre prevention of mother-to-child transmission (PMTCT) trial in sub-Saharan Africa evaluating the PMTCT efficacy of triple therapy until cessation of breast feeding compared to short course zidovudine monotherapy in a predominantly breast feeding population. Following unexplained discrepancies during objective adherence assessments, a sub-study was conducted at one site to examine the underlying adherence issues... CONCLUSION: Antenatal women in northern rural KwaZulu-Natal face significant challenges in taking antiretroviral PMTCT prophylaxis.
Clinical Trials Related to Retrovir (Zidovudine)
Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine [Active, not recruiting]
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown
to be active in vitro against a wide range of clinical isolates (including those resistant to
existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy
for 10 days reduced HIV-1 viral load by up to 1. 6 log, consistent with currently available
agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at
300 mg twice daily. No significant effects were seen on the QTc interval. The goal of this
study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when
each are combined with two other antiretroviral agents, in patients who are previously naive
to antiretroviral therapy. This study will involve approximately 200 centers from around the
world to achieve a total randomized subject population of 1071 subjects. Patients will be
randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to
zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily
added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily)
added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over
approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks
of treatment. This may be extended for an additional 3 years depending on the results at 96
weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24,
32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4,
8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn
twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857)
pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for
non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram
at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be
performed, at selected centers, at study entry and week 96. Patients will be asked to
complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96.
A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection [Completed]
Primary: To determine whether the combination of zidovudine/zalcitabine/interferon alfa-n1
(Retrovir/HIVID/Wellferon) can produce complete responses (i. e., CD4 counts return to >= 800
cells/mm3 for more than 24 weeks) in patients with virus sensitive to all three agents. To
determine the antiviral effect of the combination therapies as evidenced by measures of
quantitative viral load performed at select study centers only.
Secondary: To determine the effectiveness of Retrovir/HIVID and Retrovir/HIVID/Wellferon in
maintaining or increasing CD4 counts and preventing disease progression as evidenced by the
development of an AIDS-defining indicator disease. To determine the effect of these regimens
on secondary measures of clinical status (e. g., performance score, weight change, and
secondary infections) and on measures of virologic activity such as serum p24 antigen. To
assess the safety and tolerance of these regimens.
Safety of Reduced Dose Zidovudine (AZT) Compared With Standard Dose AZT in Antiretroviral-na�ve HIV-infected Patients [Recruiting]
The primary objective of the study is to compare the tolerance and safety between a low-dose
Zidovudine (AZT) containing regimen (200 mg BID) and a standard dosage (300 mg BID) in HIV
patients initiating a first line antiretroviral therapy. The investigators expect that the
low-dose regimen will show improved tolerability and safety compared to the standard dosage,
with significant reduction in number of patients experiencing a new grade 1 to 4 anaemia or
increasing their anaemia grade during the first 6 months of treatment.
The secondary objectives of the study is to compare the efficacy of the two dosing regimen,
as measured by classical clinical and biological markers: the number of new AIDS defining
illness, the mortality rate, the proportion of patients achieving virological success and
the mean CD4 cell count increase from baseline.
Zidovudine, Interferon Alfa-2b, and PEG-Interferon Alfa-2b in Treating Patients With Human T-Cell Lymphotropic Virus Type 1-Associated Adult T-Cell Leukemia/Lymphoma [Recruiting]
RATIONALE: Human T-cell lymphotropic virus type 1 can cause cancer. Zidovudine is an
antiviral drug that acts against the human T-cell lymphotropic virus type 1. Giving
zidovudine, interferon alfa-2b, and PEG-interferon alfa-2b together may stimulate the immune
system and slow down or keep the cancer cell from growing.
PURPOSE: This clinical trial is studying how well giving zidovudine together with interferon
alfa-2b and PEG-interferon alfa-2b works in treating patients with human T-cell lymphotropic
virus type 1-associated adult T-cell leukemia/lymphoma.
A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell [Completed]
PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the
combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of
treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage.
SECONDARY: To compare and evaluate other markers of immunologic and virologic activity in
patients receiving nevirapine/AZT versus AZT alone. To compare the effects of the two
regimens on clinical signs and symptoms. To evaluate the safety and tolerance of the two
Reports of Suspected Retrovir (Zidovudine) Side Effects
Foetal Exposure During Pregnancy (76),
Premature Baby (23),
Maternal Exposure During Pregnancy (19),
Patent Ductus Arteriosus (11),
Foetal Growth Restriction (10),
Congenital Cytomegalovirus Infection (9),
Tricuspid Valve Incompetence (8), more >>
Page last updated: 2014-04-11